Receipt, Issuance, Performance, Regeneration, Use, Cleaning, Storage and Rejection of GC Columns

  1. Objective

To lay down the procedure for Receipt, Issuance, Performance, Regeneration, Use, Cleaning, Storage and Rejection of GC Columns.

  • Scope

This SOP is applicable for all the GC columns used in Quality Control Laboratory. 

  • Responsibility

QC Chemist/Officer QC-Officer/ QC-Executive     : To follow the procedure.

  • Accountability:

Head QC                                     : For system compliance.

  • Procedure:
    • Procurement of analytical Column:
      • Procure the column as per the requirement in the method of analysis.
      • Ensure the column dimension, packing material; particle size and make are as per user requirement.
      • On receipt of the new column verify the information as per PO. Physically check the column for the following:
      • No damage
      • Dimensions (length, diameter) match as per PO.
      • Packing and particle size matches as per PO.
      • Write the date of receipt on the certificate of the Column.
      • On receipt of GC Columns enter the details in column Inward register. It contains the details like Date of receipt, Name of column, Dimension / Particle size, Column Sr. No. / Lot No/Batch No., Date of Issuance and date of Destruction.
      • Column number shall be assigned serially for GC.
  • Suitability verification:
    • Perform for intended product when required.
    • Enter the information in issuance register
    • Connect the column to GC system.
    • Conditioned the GC column for 30 minutes before starting and after completion of analysis.
    • Check and record the system suitability parameters as per STP.
    • If the system suitability parameters are within acceptance criteria, the column passes the system suitability test.
    • The Performance Certificate received along with the column is reviewed and attached with the System Suitability report of first analysis.
    • If the column fails the system suitability test it shall be rejected, a record shall be maintained and column shall be returned back to purchase department.
    • Head QC/Authorized person shall approve column performance report.
    • Conditioning of column
      • Set the oven temperature to 240ºC and conditioned the new column for 120 minutes.
    • Use of column
      • Select the column which is required as per STP. Make entry in the log book in Annexure-III for the column and record the usage details.
      • Follow the STP for the test to be carried out.
    • Destruction of column
      • Initially column conditioning may be performed to resolve the issues related to peak elution.
      • If column conditioning is not able to resolve the peak related problem then it shall be decided to discard the column.
      • QC-Head shall takes the decision to discard the column and enter the details in column Inward register.
  • Annexure
  • NA
  • Reference (S)

In house

  • Glossary

A.R.No.                   : Analytical Report Number

B.No.                        : Batch Number

DMSO                    : Dimethyl Sulphoxide

HPLC                     : High performance liquid chromatography           

QA                          : Quality Assurance

QC                         : Quality Control     

RSD                       : Relative Standard Deviation

SOP                       : Standard Operating Procedure

STP                        : Standard test procedure

PO                          : Purchase order

  • Revision History
Rev. No. Details of changes Reason for change

Bhanu Pratap Singh


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